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Safety of AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL.
||A Pharmacodynamically-guided, Dose-escalation, Phase I Study to Assess the Safety of AFM11 (Recombinant Antibody Construct Against Human CD19 and CD3) in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL.
||Andreas Klein, MD
Determine whether AFM11 is safe and active in the treatment of relapsed and/or non-responsive Non-Hodgkin Lymphoma (NHL).
- Must have relapsed or non-responsive follicular lymphoma, marginal zone lymphoma, lymphoplasmocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal B-cell lymphoma, or transformed B-cell lymphomas.
- Must have relapsed or were non-responsive to the approved standard therapy, which must have included 1 treatment line with rituximab plus chemotherapy.
- Must have disease progression requiring therapy
- Must not have abnormal organ function as determined by lab values defined in the protocol.
- Must not have had an Autologous Hematopoietic stem cell transplant (HSCT) within 12 weeks prior to start of study treatment.
- Must not have had cancer chemotherapy within 4 weeks prior to start of study treatment
The study will last 4 weeks with four study visits per week. Blood samples (2 mL) for PK will be taken post-infusion during weeks 1 and 4 and before the infusion during weeks 2 and 3. Blood for immunology studies will be drawn at almost every study visit post infusion (5 mL). An MRI and CT scan will be done at screening. Depending on what portion of the trial study subjects enroll to, subjects will be required to stay inpatient for treatment and observation.